AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import Eculizumab (Soliris) Concentrate for Solution for Infusion 300 mg (10 mg/ml). This breakthrough drug targets two critical and rare conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH) & Atypical Hemolytic Uremic Syndrome (aHUS)
“This is to inform that AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India, for Eculizumab concentrate for solution for infusion 300 mg (10mg/ml) (Soliris),” the company announced.
The approval under Form CT-20 enables AstraZeneca to launch Soliris in India, pending any additional statutory clearances. This milestone strengthens the company’s commitment to providing cutting-edge treatments for rare and complex conditions. Shares of AstraZeneca Pharma reacted positively, briefly climbing by 1.98% to Rs 6,583.65 after the announcement.
Doctors can now anticipate access to a globally acclaimed solution that addresses critical unmet medical needs in hematology and nephrology.
Adverse Reactions
•Headache, nasopharyngitis, back pain, nausea (≥10%), diarrhea, hypertension, respiratory infections, abdominal pain, vomiting, anemia, edema, UTIs, pyrexia (≥20%), Musculoskeletal pain (≥10%), contusion (≥10%).
Warnings
• Meningococcal Risk: Increased risk of life-threatening Neisseria meningitidis infections.
• Vaccination: Complete meningococcal vaccination at least 2 weeks before starting therapy, following ACIP guidelines.
• Monitoring: Watch for early infection signs and act immediately if suspected.
